CORTEX DOUBLE HELIX SAMPLER— 510(k) K800003
Substantially EquivalentCortex Research Corp.
FDA 510(k) clearance K800003 for CORTEX DOUBLE HELIX SAMPLER, Substantially Equivalent on 1980-02-01. Applicant: Cortex Research Corp.. Device class: 1.
Clearance details
- Applicant
- Cortex Research Corp.
- Product code
- Code GLE
- Device class
- Class 1
- Regulation
- 21 CFR 862.2050
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code GLE
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